- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02119923
Tackling Depression and Anxiety: A Working Memory Intervention
18. april 2014 opdateret af: Ingmar Franken, Erasmus Medical Center
Effects of Working Memory Training in a Depressed and Anxious Sample
Anxiety and depression are both associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information.
Due to these WM impairments anxious and depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information.
This study explored whether training WM decreases these impairments and reduces clinical symptoms and rumination.
Eighty-four individuals diagnosed with major depression and forty-nine individuals with an anxiety diagnosis executed WM or control tasks three times a week, during four weeks.
Before, after training and at a two months follow-up measurement depression and anxiety symptoms, WM capacity and rumination behaviour were assessed.
Training WM did only result in a reduction of anxiety symptoms in the depression group.
These findings are inconsistent with promising results of individual studies showing training WM result in an enlarged WM capacity and a decrease of psychopathological symptoms.
However, our results are in line with recent meta-analyses and reviews which show that WM training do not lead to generalized effects and therefore, doubt the clinical relevance of WM training programs.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
240
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Zuid Holland
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Rotterdam, Zuid Holland, Holland, 3000 DR
- Erasmus University Rotterdam
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 68 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Major depression diagnosis
- Anxiety disorder diagnosis
Exclusion Criteria:
- Current psychosis
- Current substance dependency
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Træning af arbejdshukommelse
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The WM consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task.
The Number-letter task trains the ability to shift between task relevant stimuli.
Participants need to shift between four categories.
In the Updating task participants receive a set of three words in which they have to compare the two consecutive words on emotional valence (positive or negative) to train their updating skills.
Participants executed the training three times a week during four weeks.
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Placebo komparator: Placebo træning
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Both the WM and the placebo training consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task.
To prevent training WM the placebo training was a simplified version of the Number-letter task in which shifting was not required.
In the Updating task the placebo group only had to count the number of positive or negative words.
Participants executed the training three times a week during four weeks.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Beck Depression Inventory Second Edition (BDI-II) score change between pre and post training and at follow-up measurement (2 months after post measurement)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Depression is measured with the BDI-II
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
State-Trait Anxiety Inventory (STAI) scores change from pre to post training and to follow up measurement (2 months after post measurement)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The STAI measures state, trait and total anxiety
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Ruminative Response Scale (RRS) score change between pre and post training and follow up (two months after post)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The RRS measures rumination
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Symmetry Span score change between pre and post training and at follow-up measurement (2 months after post measurement)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The Symmetry Span measures working memory capacity
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Internal shift task score change between pre and post training and at follow-up measurement (2 months after post measurement)
Tidsramme: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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The internal shift task measures working memory capacity
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Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Elke Geraerts, PhD, Erasmus University Rotterdam
- Studieleder: Sabine Wanmaker, MSc, Erasmus University Rotterdam
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2011
Primær færdiggørelse (Faktiske)
1. oktober 2011
Studieafslutning (Faktiske)
1. oktober 2011
Datoer for studieregistrering
Først indsendt
8. april 2014
Først indsendt, der opfyldte QC-kriterier
18. april 2014
Først opslået (Skøn)
22. april 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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